UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038607 |
|---|---|
| Receipt number | R000044001 |
| Scientific Title | The effects of agarwood's (Jin-kou's) scents to autonomic nervous system of female nurses after night shifts: a double-blind randomized controlled crossover study |
| Date of disclosure of the study information | 2019/11/19 |
| Last modified on | 2019/11/29 13:30:37 |
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Basic information
Public title
The effects of agarwood's (Jin-kou's) scents to autonomic nervous system of female nurses after night shifts: a single-blind randomized controlled crossover study
Acronym
The effects of agarwood's (Jin-kou's) scents to autonomic nervous system
Scientific Title
The effects of agarwood's (Jin-kou's) scents to autonomic nervous system of female nurses after night shifts: a double-blind randomized controlled crossover study
Scientific Title:Acronym
The effects of agarwood's (Jin-kou's) scents to autonomic nervous system
Region
| Japan |
Condition
Condition
nurse
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of scents of agarwood's (Jin-kou's) scents on female nurses' stress relief who after night shifts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parasympathetic nerve system activity
Key secondary outcomes
Sympathetic nerve system activity
Cortisol in saliva
VAS(Visual Analog Scale)
Profile of Mood States-Brief Form 2nd Edition
Perceived Stress Scale(PSS)
Japanese version of the Professional Quality of Life Scale(ProQol)
The Hospital Anxiety and Depression Scale(HADS)
Japanese version of the Pittsburgh Sleep Quality Index(PSQI-J)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Agarwood (Jin-kou)
Interventions/Control_2
Placebo (Non-intervention)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1)female nurses after night shifts
(2)Aged 20 years old or older but younger than 60 years old
Key exclusion criteria
(1)Person who has pulmonary disease, cardiovascular disease, olfactory disorder, or who are under treatment
(2)Person who has experienced the allergic symptoms such as headaches or dermatitis by medication or aromatics
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kohzuki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku Sendai
TEL
022-717-7353
kohzuki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | JIE |
| Middle name | |
| Last name | LI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku Sendai
TEL
022-717-7353
Homepage URL
li.jie.t2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Kodo CO.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
nstitutional Review Board, Graduate school of Medicine, Tohoku University
Address
2-1 Seiryo-cho, Aoba-ku Sendai
Tel
81-22-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 18 | Day |
Last modified on
| 2019 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044001
